Saluda Medical said today that it won CE Mark approval in the European Union for its Evoke closed-loop spinal cord stimulation device.
Australia- and Bloomington, Minn.-based Saluda, which is backed by both Boston Scientific and Medtronic, said the first commercial implantations have already occurred, in Holland. The Evoke device is designed to measure the response to therapy and adjust it on the fly.
“We have been anticipating the launch of the Evoke system for some time and are delighted to be the first commercial users of this important new technology. Our team is dedicated to providing patients with the most impactful innovations to help manage their chronic pain and we are already seeing positive initial results with the Evoke system. For the first time we can directly measure each individual patient’s neurophysiological response to SCS and use this objective data to guide how we program the system to best treat their individual pain complaint. This is a disruptive advance in the field of neuromodulation that will benefit a huge number of patients suffering with refractory pain conditions,” said Dr. Harold Nijhuis, of Nieuwegein’s St. Antonius Hospital, where the first Evoke procedures were performed. “Without the ability to measure, we cannot overcome the variability of spinal cord activation. With Evoke SCS, we can set each patient’s individual therapeutic window and let the device adjust on every pulse, millions of times per day, to meet their need.”
“This is of course an important moment in the development of our organization, but it is also a key milestone for the field of neuromodulation as a whole. Evoke is the first and only ECAP-controlled, closed-loop SCS system which, after almost a decade in development, is now commercially available to clinicians to help them treat patients suffering with chronic pain. Our efforts are now focused on ensuring the excellent patient outcomes we have seen in our pre-market clinical studies are replicated, post-approval, in Europe, and scaling our business to meet the burgeoning demand for the Evoke system,” added CEO John Parker.